Summary

Overview

Work History

Education

Skills

Additional Information

Indoor games, Traveling, Music

Timeline

Dr. Kalpesh Shah

Clinical Research (leadership Role)

Summary

Executive Leader: Clinical Trials, Bioequivalence and Phase I Studies Clinical Research Operations Management Biosimilar Development PK and BE studies Profile Summary With over two decades of robust experience in leading business change, that delivers sustainable operational outcomes and long-term success in the field of clinical research. Spearheaded the clinical research department for early and late-phase development programs for diverse projects. Demonstrated success in consistently providing leadership, strategic oversight, and guidance on Clinical Operations to ensure quality, timeline, resources, and budget goals are met. Provided input on operational components of legal documentation and statements of work as required for new and returning sponsors, vendors, and suppliers. Comfortable multi-tasking in a fast-paced environment and able to adjust workload based upon changing priorities. Assisted as an advocate for clinical operations needs/resources at a senior management level. Demonstrated ability to drive clinical trial activities: i.e. experience in all aspects of study start-up and conduct, regulatory obligations, adverse event reporting, and budgeting. Accomplished Regulatory submission - FDA, EMA, India, and other Emerging markets, including Clinical development plans and strategy towards study conduct, regulatory submission, and approval for NDDS, Biosimilars, generics, Clinical equivalence studies, PK in patients, etc. Influential people manager, build and nurture high performing teams, represent all aspects of Clinical Operations and facilitate updates as required to the Executive Committee, Project Teams, Board of Directors and other key internal stakeholders. Key Skills: Project Management Clinical Operation Medical Writing Strategy Planning Technical Support Business Development Clinical Plan Development Process Improvement Operational Excellence Training and Mentoring Transformation and Innovation Regulatory Submission Clinical Approvals Compliance Management Personal Traits: Big Picture Perspective ~ Influential Leadership ~ Systematic Planner ~ Good Listener ~ Self-Motivated ~ Recognized People Manager.

Overview

years of professional experience

years of post-secondary education

Work History

Head -Clinical

Vimta Labs Ltd

06.2022 - Current

Spearheading Clinical Trials, Bioequivalence and Phase I Studies, Regulatory group, Data management group, and Statistics team
Increasing accuracy by exploring different OSPITL and investigators
Providing direct oversight and management of operations and personnel involved in clinical operations, data management, biometrics, medical writing, and other functional groups as assigned
Ascertaining that clinical trials are resourced in accordance with timelines and good quality practices
Eliminating risks as well as attaining the highest quality standard by concluding the USFDA audit in Jan 2023 with Zero 483
Led a team of 90 professionals to drive various projects for Indian and Global sponsors aimed at various regulatory submissions
Providing operational and clinical expertise and strategic insights to develop a life-cycle strategy and evaluation of new programs to be prioritized/advanced into clinical development
Accomplishing 5o5 b2 projects as well as managing NDA’s new drug application project
Driving technical discussions by facilitating support to the business development team
Implementing best practices and standards for trial management in collaboration with other members of the clinical operations team, including the establishment of SOPs
Planning clinical headcount and hiring needs to meet program workload demands
Ensuring smooth run of operations by maintaining seamless coordination with the sponsors
Developing clinical timelines and budget forecasts and being accountable for tracking and delivering accordingly
Attaining high standards of sponsor satisfaction by responding to their queries
Reducing errors by facing sponsor audits and handling third-party audits.

Senior VP - Clinical Research

Sami-Sabinsa Group

01.2019 - 05.2022

Led, mentored, motivated and retained a team of 20 professionals to drive project operations and clinical research projects for cosmetics, nutraceuticals, and drug product across Mumbai and Bangalore locations
Defined project management chart and FTE allocation for each project to achieve project milestones within the budget and delivery frames by resolving complex clinical research problems based on an in-depth evaluation of data and various factors
Slashed down the costs by 70% through initiating to execute numerous projects within the in-house facility by devising the entire structure from scratch and utilizing available resources during pandemic
Initiated to establish rescue plan, remote monitoring strategy, and patients’ home based lab analysis to drive patients’ recruitment and retention for laboratories and hospitals by monitoring site level activities, keeping external and internal team members motivated and addressing their issues proactively due to COVID impact
Designed and facilitated oversight of clinical programs to include integrated clinical, regulatory, strategies, in close collaboration with the sites and clinical development stakeholders
Consistently met regulatory requirements/compliance of US FDA and faced to pass through DCGI studies aptly by streamlining the departmental functions, developing SOPs, work instructions and defining proper flow process
Increased operational efficiency, team capacity and capabilities by driving automation in several processes, implementing remote monitoring process, thereby saved significant amount of cost and man-hour efforts
Enforced stringent control over finances by eliminating the advance payment term to overcome COVID 19 impact and structured the payment to be released on milestone basis to achieve a consistent flow of revenue to the organization and retaining the existing clients/stakeholders
Delivered savings through eliminating purchase of software by outsourcing the core activities to third party vendors in a cost effective manner
Handled clinical trial projects for different therapeutic segments i.e., diabetes, liver disorders, ophthalmology, CNS, dermatology, metabolic disorders, COVID-19 etc
Obtained approval for the Drug product by suggesting amendment in the study design and achieved the DCGI clearance which was pending for more than a year
Met compliance with Company guidelines, Regulatory authority regulations and safety standards by planning and implementing quality checks for clinical projects and facilitated leadership and direction
Led clinical and regulatory affairs, including departmental budgets in all areas of responsibility and secured adequate resources to meet business objectives within financial restraint
Initiated numerous global projects spread across USA and Australia, developed manuscript, publication, and made presentations during Investigators meeting.
Hired and managed employees to maximize productivity while training staff on best practices and protocols.

General Manager Clinical Research

Reliance Life Sciences Pvt Ltd

Mumbai

01.2006 - 12.2018

Clinical Research Services group
Spearheaded, monitored and managed clinical operations, quality systems, and administrative functions, ensuring operational efficiency, quality, and cost effective management of resources
Developed and maintained a thorough understanding of RLS management system requirements and therapeutic needs for clinical research
Realized short-term and long-term financial and operations goals consistently by conceptualizing and implementing strategies and innovative programs
Accomplished CTD/eCTD submission of Bioequivalence documents, design of the complete clinical plan for Biosimilars, and design of PKPD studies and efficacy studies for Biosimilars
Collaborated with the pharmacovigilance, regulatory, bio-analytical, and DM departments for the smooth execution of the project and facilitated training to CRA on monitoring plan, project execution, and documentation
Aligned personal and functional goals with RLS objectives and measure performance against objective standards
Facilitated accurate and timely information to the Management regarding the quality and compliance status of the CR operations
Maintained seamless collaboration with other groups and supporting departments for synergetic operations
Attained high standards of performance standards by conducting periodic performance evaluations for directly reporting staff and identifying gaps as well as organizing guidance sessions to bridge the performance gaps
Ensured effective training programs and knowledge management to realize the full potential of the organization as a whole
Drove multiple efforts to ascertain compliance with Scientific Engagement principles and standards in all activities at the area level and ensured that overall governance activities are managed proactively and with urgency
Improved productivity, and efficiency, ensuring that the organization’s policies complied with service quality norms, and resolved discrepancies between study documents, including protocols, CSR, CRF, tables, and listings
Managed Advance Diploma in Clinical Research program for students and trained them on clinical research activities
Awarded “Long Service Award” against serving in a results-driven manner for over 15 Years and stepping up the ladders of success since joining as a Manager to achieving the position of General Manager
Received “Employee of the Year” award for delivering excellent performance in Jan 2015.
Managed budget implementations, employee reviews, training, schedules, and contract negotiations.

Group Leader - Clinical Research

Torrent Research Center

04.2004 - 12.2005

Made significant contribution during ANVISA – Brazil inspection in the month of Nov 2004
Managed clinical trials right from activities, including budgeting to archival and designed clinical trial protocol / CRF and other study documents in Phase III
Prepared clinical trial protocol and CRF and conducted Post Marketing Surveillance (PMS) study - Phase IV
Created and reviewed clinical part of the dossier for international submission as per regulatory requirements
Carried out on site monitoring, source data verification, data collection, cleaning, compilation and review as well as collecting Data from respective centers
Managed publication of in-house medical journal “Contemporary Medicine” whilst maintaining seamless interaction with the authors, review committee, publication house etc
Writing articles including review articles and proof reading of articles
Prepared clinical trial SOPs, coordinating with DCGI to obtain statutory approvals and preparing final report of Clinical trials for submission to regulatory body (As per ICH E3).

Intas Pharmaceutical

06.2000 - 03.2004

Clinical Research and Regulatory Affairs

Scientific services Officer

Sanofi Aventis Pvt Ltd

01.1998 - 05.2000